MAD Trial: Myopia Atropine Dose

• Status: Not yet recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Atropine

Criteria

Inclusion Criteria:

• Children aged 6 to ≤ 11 years with bilateral myopia

• Onset of myopia ≥ 4 years of age

• History of progression ≥ -0.5D/yr.

• SER of at least -1.50D and no greater than -6.00D in each eye measured using cycloplegic auto refraction

• Intraocular pressure < 21 mm Hg in each eye

• Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye

Exclusion Criteria:

• Allergy to atropine or other excipients of the eye drops

• History of amblyopia or strabismus

• History of retinal dystrophy or systemic disorder

• Abnormal ocular biometry aside from axial length

• History of glaucoma

• Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year).

• Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication.

• The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., < 2 weeks)

• Prior myopia treatments.

• Employees of the study center and their family members.